Universal diagnostic platform

ABSTRACT

A portable medical analyzer comprising a sampling module with a sample port for receiving body fluid, an assay sensor module for analysis of the body fluid, an analytical detector module with detection of information from the assay, and a communications module for transferring the information to a remote location via a wired or wireless network.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. Ser. No. 12/359,891, filedJan. 26, 2009, which is a continuation of U.S. Ser. No. 10/892,874,filed Jul. 16, 2004, which is a continuation of U.S. Ser. No.09/981,483, filed Oct. 16, 2001, all of which applications are fullyincorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to portable medical devices. Moreparticularly to a point-of-care (“POC”) medical diagnostic system withcommunication capabilities.

2. Background of the Invention

Over the past 30 years, the average life expectancy of North Americanshas increased by approximately 13 years, contributing to a rapidincrease in the number of people over the age of 65. Thus, there hasbeen a dramatic growth in total health care spending as the populationages. As a result, the use of screening and monitoring diagnostics forearly intervention, improved treatment and monitoring has become animportant aspect of health care.

Technological advances have facilitated the development of easy-to-use,rapid diagnostic devices which can be used in a POC setting, closer tothe patient, and that have the ability to pick up disease at an earlierstage. POC testing is attractive because it rapidly delivers results tothe medical practitioner and enables faster consultation with thepatient. Thus, early diagnosis can enable the practitioner to commencetreatment sooner, perhaps leading towards improved patient outcomes.Examples of POC tests include blood chemistry, such as glucose,hematology, immuno-diagnostics, drugs of abuse, serum cholesterol, fecaloccult blood test (“FOBT”), pregnancy, and ovulation. In addition manynew types of analytics now being carried out in the DNA arena (such asDNA based assays, immuno assays, proteomics and genomics) which arelikely candidates for POC testing.

One such example of the potential benefit from a portable medicalanalyzer in the use of DNA testing is to help doctors prescribe medicinetailored to the particular patient's genotype. Gene-array chiptechnology determines a patient's genetic information, which ahealth-care provider may use to classify the patient in particulargenotypes. Medications respond differently depending on the particularpatient's genotype. By matching the most effective medication for aparticular genotype, the patient may receive superior care by avoidingadverse reactions, while maximizing drug efficacy.

A portable medical analyzer provides the additional benefit offacilitating the remote patient monitoring of a patient's medicalstatus. The effectiveness of monitoring systems depends not only on therange of tests reported and their accuracy, but also on the frequencyand rapidity of information gathered regarding the patient's healthstatus. A portable medical device can run a range of tests, which covermost of the tests required for diagnosis or therapy monitoring,including blood gases, electrolytes, hematocrit, and various metabolitessuch as glucose.

Combining biochemical parameter results from the POC device withphysiological parameters (such as ECG, respiration rate, temperature andblood pressure) permits integration of vital signs and blood chemistryon a real time basis, for better disease management. Results can then betracked over time for trend analysis. Portable medical analyzers alsohave application in the clinical research setting for remote patientevaluation in post surgical recovery, drug therapy and novelpharmaceutical testing using the remote communications ability.

Current POC devices do not provide an integrated solution for patientself-testing to sample acquisition, testing, analysis and connectivityto remote centralized healthcare. Accordingly it is the object of thisinvention to provide a portable, highly integrated, multi-parametermeasurement instrument with IT solutions for data collection,transmission, analysis and on-line decision support. This is achieved byan integrated approach to sample acquisition, a miniaturizedmulti-parameter low cost test strip or “cartridge,” a companion portableinstrument and an information solution for connectivity via a wired orwireless network.

SUMMARY OF THE INVENTION

In accordance with the invention, a method and apparatus for utilizing aportable medical analyzer is provided. The method comprises obtaining abody fluid transmission of the fluid to a cartridge, the cartridgecomprising at least one assay sensor module, positioning the cartridgeinto an analytical detector module, where positioning the cartridgebreaks a pressure seal on the cartridge causing the body fluid to flowto an assay sensor on the cartridge, using the analytical detectormodule to detect the results of the assay sensor, connecting theanalytical detector module to a communication module, and transferringthe results from the analytical detector module to the communicationmodule.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of theinvention and together with the description, serve to explain theprinciples of the invention.

FIG. 1 illustrates an embodiment of sampling, assay sensor, analyticaldetector, and communication modules according to the present invention.

FIG. 2 illustrates a cut-away view of an embodiment of combined samplingand assay sensor modules with an analytical detector module of aportable medical analyzer.

FIG. 3 illustrates a cross-sectional view of an embodiment of an assaysensor module layout.

FIG. 4 illustrates a flow chart of a method of operation for anembodiment of a portable medical analyzer.

FIG. 5 illustrates a block diagram of an embodiment of a communicationmodule within a network environment.

FIG. 6 illustrates a flow chart of an embodiment of a method ofoperation for a portable medical analyzer.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to the exemplary embodiments of theinvention, examples of which are illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers will be usedthroughout the drawings to refer to the same or like parts.

Overview

In accordance with the present invention, a portable medical analyzer isdescribed. One aspect of the present invention is a portable medicalanalyzer capable of performing a variety of diagnostic tests. Portablemay refer to the self-contained nature of the analyzer. Portable mayfurther refer to a hand-held format for the analyzer. As illustrated inFIG. 1, a portable medical analyzer 100 may include a sampling module110, an assay sensor module 120, an analytical detector (AD) module 130,and a communications module 140.

In one aspect consistent with the present invention, sampling module 110is a one-step, painless, ergonomic blood sample acquisition module,which provides capillary blood for introduction into an integrated assaysensor module 120. Assay sensor module 120 may be a highly integrated,low-cost, disposable diagnostic cartridge supporting parallel testing ofmultiple established and emerging diagnostic parameters from body fluidsincluding but not limited to capillary blood, venous blood or bloodgases. Analytical detector module 130 employs a modularized hardwaretechnology combining appropriate detection and communicationtechnologies. Analytical detector module 130 module may accept adisposable cartridge or series of disposable cartridges for the analysisof body fluids. Communication module 140, with bi-directional wirelessconnectivity to an information infrastructure which can provide agateway to laboratory and clinical information systems, has aninformation infrastructure for integrating the use of decentralizeddiagnostic technologies within general patient care processes.

Each type of module can be a removable interchangeable componentallowing for module packaging and disposability. Various combinations ofsampling, assay sensor, and analytical detector modules couldaccommodate a very wide range of diagnostic tests, from blood glucosetesting to DNA typing. Any of these combinations would be able toutilize a common communication and information infrastructure adding tothe flexible nature of this architecture.

Sampling Module

In a portable medical analyzer, sampling module 110 can receive fluidsusing a variety of methods. The sampling module can acquire a number ofbody fluids, including but not limited to blood. The fluid can be aliquid and/or a gas. The sampling acquisition port of the portablemedical analyzer captures body fluid for testing. The port can receivefluids from a variety of means of sample acquisition and or transfer,including but not limited to, lancing, injection, pipette, intravenous,and catheter. In a non-limiting embodiment, a lancet punctures the skinand a sample collection port, which can be positioned to correspond withthe wound created by the lancet, channels the blood to a sample testarea or a sample storage chamber. Such channeling can be passive(gravity, capillary flow, etc.) or active (aspiration, vacuum, etc.).

The lancet may be advanced and/or retracted by a variety of mechanical,electrical, electromechanical, piezoelectric, and electromagnetic, or acombination of these types of driving mechanisms. Mechanical drivingmechanisms can contain a spring, cam or mass actuators to drive thelancet. These include cantilever springs, diaphragms, coil springs, aswell as gravity plumbs to actuate the lancet. Typically, the device ispre-cocked, or the user cocks the device. The device is held against theskin and the user mechanically triggers ballistic launch of the lancet.Other types of driving mechanisms may use electrically based driving andtriggering methods, electrical, electromechanical, piezoelectric, andelectromagnetic, or a combination of these types of driving mechanisms.

In one embodiment of the invention, a sampling module 110 and assaysensor module 120 are bundled together in one cartridge. This embodimentis described in further detail with the description of FIG. 2 below.

The driving mechanism can be combined in the sampling module, assaysensor module, or analytical detector module. It is desired that thelancet in a module be disposed of with the module for biohazardpurposes. It is desired that an expensive mechanism, i.e. electronic, bebuilt into the non-disposable portion of the module e.g. communicationmodule or analytical detector module, where as an inexpensive drivingmechanism, i.e. cantilever spring may be built into the disposablemodule. In the embodiment where the sampling and assay sensor module arecombined on one cartridge, such an expensive driving mechanism can becontained on analytical detector module 130, as discussed in FIG. 2.

Alternatively, a sampling module 110 may be used to draw blood into asample acquisition port, which may be separate from the assay sensor.Such a modular configuration provides flexibility in linking onesampling module 110 with several assay sensors. Blood may thus beallocated to each of the assay sensors thereby, requiring only onelancing event and reducing the donor's discomfort.

Alternately, a sampling module 110 can be coupled to an assay sensormodule such that the interface is standardized. For example the MemoryStick Duo® (Sony, Japan) provides a modular solution where the samplingmodule with a Memory Stick® interface can receive assay sensor modulesconfigured to digital media standards.

FIG. 2 shows a analytical detector module 130 comprising a slot forcartridge 10, wherein sampling module 110 and assay sensor module 120are contained. Cartridge 10 is disposable and houses lancet 16. The term“disposable” refers to a fungible feature of the portable medicalanalyzer, such as a lancet, assay sensor, or cartridge which can be usedfor one lancing cycle or one analysis and is then discarded. Lancet 16connects to driver 40 that contains the driving mechanism for advancingand retracting the lancet. Lancet 16 is initially retracted and uponretraction embedded within the cartridge 10. The term “embedded” refersto the lancet being completely shielded by the cartridge when it is notlancing.

Driver 40 plugs into cavity 20 of cartridge 10. Driver 40 may bedisposable and attached to the cartridge or reusable and attached to theassay sensor. Reservoir 22 has a narrow opening sample acquisition port14 on an ergonomically contoured surface 26 for collecting the bloodfrom a donor, such as from finger 50 lanced by lancet 16. Reservoir 22may fill passively through gravity, or capillary flow, or activelythrough aspiration or vacuum collect the blood sample.

The cartridge 10 can transport the blood sample through small passages(not shown) using active pumping or passive microfluidics, to a specificlocalized assay sensor 28 for analyzing the blood, which corresponds toa corresponding location on the analytical detector module 130. Theanalytical detector module 130 can comprise chemical, physical, optical,electrical or other detecting means of evaluating the blood sample bythe assay sensor module 120.

Cartridge 10 is loaded in a slot 32 within analytical detector module130. The driver 40 contains the driving mechanism 38, which is capableof advancing, stopping, and retracting the lancet 16. The slot 32 alsocontains the detector 48 for evaluating the blood analysis of the assaysensor 28 on the cartridge 10, which corresponds to the assay sensor 28on the cartridge 10 which corresponds to detector 48 when the cartridge10 is loaded into the slot 32. Alternately, cartridge 10 can be designedwith an array of testing locations, which contain a variety of assayssensors and correspond to an array of detectors on the analyticaldetector module 130. Pins 34 on slot 32 provide electrical contactbetween the cartridge 10 and the analytical detector module 130 toenable identification of the type of assay sensor, and quality controlissues (e.g., expiration date of cartridge). Alternatively, cartridge 10can be in mechanical contact with analytical detector module 120 lockingthe cartridge 10 in place and puncturing the cartridge 10 to break avacuum seal and being fluid flow for calibration and create a pressuredifferential for capillary forces to pull the body fluid sample.

In one embodiment of the invention, the cartridge may be developed on aMemory Stick® (Sony Electronics, Japan) digital media standardinterface. Alternative embodiments contemplate other digital medialstandard interfaces including but not limited to Compact Flash®,MulitMedia Card®, Secure Digital®, SmartMedia®, or any other removableportable device. The cartridge is of an ultra compact design that has astandard size and connectivity specifications based on the respectivestandard interface. The removable cartridge can be inserted into anassay detector module 130 with a slot and connector corresponding to thestandard for PC cards or Memory Stick Duo® detachable cartridge.

Assay Sensor Module

As used herein, the term “assay sensor” refers to a substrate orlocation for conducting body fluid analysis, such as but not limited toa biochemical assay. The assay sensor module 120 provides an analyticaltesting platform for the fluid sample. In a non-binding embodiment, thesampling module and assay sensor are bundled together. Alternatively,the assay sensor may be a separate component. A sample is transportedthrough the assay sensor module to particular assay sensors, through anetwork of microtubes using active or passive transport.

FIG. 3 illustrates an embodiment of a configuration of multiple assaysensors and tubes for transport in assay sensor module 120. Assay sensormodule 120 comprises a cartridge 300, which contains multiple assaysensors 400, each of which correspond to respective detectors (notshown) on analytical detector module 130. Each assay sensor 28 canperform the same analysis, for redundant testing, or a variety ofdifferent analysis using reagents stored in reservoirs 380 in thecartridge 300. These reagents are packaged in the cartridge duringmanufacture, such that the patient does not have to replenish anyreagent to conduct the assay. Assay sensors may be chemically orbiologically active locations. A number of different types of tests canbe performed including blood chemistry, hematology, immuno-diagnosticsthose for drugs of abuse, serum cholesterol, glucose, FOBT, pregnancy,ovulation, along with many new types of analytics now being done in theDNA arena, such as DNA based assays, immuno assays, proteomics andgenomics. These tests enable analytical detector module 130 to detectcharacteristics, or information, about the fluid sample. As used herein,the term “information” refers to data determined as a result of analysisfrom the analytical testing conducted by the portable medical analyzer.

Blood coming into the cartridge via sample acquisition port 340 isstored in reservoirs 420 so that it can accumulate to volumesappropriate for the relevant assay to be performed. Reagents necessaryfor the analysis are stored and shielded in reservoirs 380 prior totheir use. A system of valves (not shown) keeps the reagents and samplefluid confined to appropriate paths in the cartridge 300. The blood andreagents are transported via active or passive transport through microtubes 320 to assay sensors 420. The micro tubes 320 may be forked to mixthe blood and reagents prior to reaching assay sensors 400.Alternatively, the blood and reagents can mix upon contact with theassay sensor.

Analytical Detector (AD) Module

In the portable medical analyzer, the AD module 130 evaluates the assaysensor in the assay sensor module via detectors, which are associatedwith the assay sensors. The AD generates signals corresponding toinformation or characteristics of the assay sensors. The AD module mayinclude signal processing devices and circuitry for the rapid processingof the signals generated by the array of detectors, which correspond tothe array of assays. A variety of detectors, including electrical,electrochemical, optical or mechanical can be used to detect resultsfrom tests on the assay sensor module. In one embodiment, the AD modulecan interface with a standard port on a portable computing device suchas a laptop computer, a personal digital assistant (“PDA”), or otherportable computing device, including but not limited to a Palm™Handheld, Handspring™ Visor or Compaq iPAQ®. Standard ports includePCMCIA, serial, parallel, USB, IEEE 1394, and other computerconnectivity standard ports.

A non-limiting embodiment of the analytical detection module 130contemplates a PC card platform, such as a Personal Computer Memory CardInternational Association (“PCMCIA”) card or Handspring™ Springboard™Module. PC cards have standard thicknesses, design and pin assignments.The PC card physical characteristics include a 68 pin physicalinterface, length 85.6 mm, width 54.0 mm, and a thickness of either 3.3mm, 5.0 mm, or 10.5 mm, depending on type. PC cards can include a slotfor a Memory Stick® or other modular standard for sampling and assaysensor modules, thereby allowing detection and measurement of the assayson the PC card. In one embodiment, many different assays can beperformed in the one detection area. The information detected by theanalytical detectors contains results from each of these differentassays. The thin versatile PC card will be able to both accept thecartridge and plug into a standard communication module for performingtests.

By virtue of the modularity of assay sensing module 120, the analyticaldetector can be adapted for a wide variety of applications. In addition,by virtue of the modularity of analytical detector module 130, it canplug into a variety of host communication or computational platforms,ranging from PDAs to bench top systems. By utilizing the variouscombinations of assay sensors and analytical detectors, measurementsystems can be configured that range from those suitable for personaluse such a glucometer, to instruments for POC hospital application, oreven laboratory measurements.

Communication Module

In the portable medical analyzer, a communication module 140 can controlboth local (onboard) and remote (external) communication. The receivercan be adapted to receive instructions and/or data from externalsources. The transmitter can be adapted to transfer the information readfrom the detector to external databases and systems in remote locations.The communication module 140 can also comprise a display adapted to showthe information read from the detector locally to a user via an LCD orother visual indicator. The remote transmission component can be awireless component. The communication module 140 plays the dual roles ofcontrolling local and remote communication.

One embodiment of communication module 140 can be a PDA, such as a Palm™PDA, a Handspring™ Visor, or a Compaq iPac®. Communication module 140can comprise of a standard PDA hardware and software including aprocessor, display, RF chip, antenna, and an operating system, which maybe expanded by using some type of PC card technology. The PDA can beprogrammed with software to read information from analytical detectormodule 130, and transmit the information remotely using an industrystandard protocol for communication of medical information.

Communication module 140 can have a local storage unit in which theinformation collected can be stored, such as a localized RAM, i.e. DRAMcontaining a database of information. The information can also be sentto and stored on a remote database. The remote database can be part ofLaboratory Information System, used to manage the information in centraland reference laboratories. The remote database can display theinformation to a clinician, who in turn can analyze the information andsend back to the user of the device instruction or comments on theresults. Any of these functions can also be performed by a localdatabase. In one embodiment, a communication module in a PDA cantransmit and receive information through radio frequency (“RE”),infrared (“IR”), or docking on a cradle as is well known in the art ofstandard ports for computer peripherals.

In one embodiment, the communication module can direct information to ascreen that displays test results to a user. In another embodiment, themodule can direct information through a bi-directional wireless system.The communication module 140 can communicate to the user, andcommunicate with an outside system as well. This connection can be madeto a lab, a database, a clinical trial or a Laboratory InformationSystem. The Laboratory Information System is an information managementsystem. The term “information management system” refers to a system thatcan be used to manage the data between the portable medical analyzer anda centralized means for collecting and processing information forfunctions including but not limited to qualified user authentication,quality control, quality assurance, quality reporting, clinicalprocesses, such as low impact on workflow, result review, decisionsupport, and business processes (such as submitting information forbilling generation, demonstrating cost-effectiveness, supportingpractice guidelines, and direct marketing). The information andinstructions transmitted to the portable medical analyzer can bedirected to the particular user based on personal identification andsecurity information.

Technically, the analyzer has many key features including reliability,security and confidentiality, content distribution, and functionalitydistribution (such as a application service provider). The analyzer canbe connected to a central system, or it can stand alone. Once connectedto a system, synchronization can take place. At the remote database endof the system, security and confidentiality are supported by creatingauthorization and authentication schemes to limit the access to data.The functionality distribution includes the creation of multi-tierdisruption models, which may include localized computation orcentralized server based computation. The functionality of the system isadaptive based on the availability of local or remote resources.

In one embodiment, the data collected can be used for blind testing. Abrokering system can be structured based on the collected personalmedical records. The confidentiality of the system allows individuals tosell their medical data anonymously to customers. The customers can thenuse the data to develop medical technology or evaluate a heath caresystem.

In another embodiment, a patient management system can be adapted toapplication distribution and information management. The system uses theportable medical analyzer and provides health care organizations withinformation integration and access to administrative, data managementand decision support applications at the point of care.

In another embodiment, the analyzer can be adapted to receiveinstructions from an administration system to automate processes such ascalibration. The device can be in constant communication with a centralhospital server system. At regular intervals the server can send acommunication to the device that calibration is necessary. In oneembodiment, the user can take a calibration cartridge and insert it intothe device for calibration. The server can then either confirm that thedevice is calibrated or tell the user the device must be recalibratedmanually.

In another embodiment, the analyzer can be used for viewing ofhistorical data such as previous results and patient trends. Theanalyzer can download past patient results, or store past patientresults locally, and after testing show the patient not only the currentresults but also where they fall within historical trends.

In another embodiment the analyzer can be a part of the UniversalConnectivity Standard for Point-of-Care, for which further informationmay be forward at www.poccic.org. Using the connectivity standards, thedevice may be connected to both other devices and major medical orhospital systems. The communication can take place via an IR port,wireless networks or through connected phone lines.

In another embodiment, an analyzer connected to an LIS can compareresults from diagnostic tests run in the laboratory of full-sizeanalyzers and develop correlation tables between results from theportable medical analyzer and the laboratory results.

Method of Use

FIG. 4 illustrates a flow diagram of an embodiment of a method for POCdiagnosis using a portable medical analyzer as described in FIG. 1.Sampling module 110 is integrated into assay sensor module 120 in theform of a cartridge with a lancet. The user takes the cartridge andpresses it against a finger. The driving mechanism trigger from thepressure of the trigger or a button on the analyzer. The drivingmechanism propels the lancet, which lances the skin and draws body fluid(step 410). Once the cartridge is locked into analytical detector apressure seal is broken causing calibration fluid, reagents and sampledbody fluid to flow through the cartridge (step 420). The body fluidflows to the location of the assays on the cartridge, allowing for thechemical analysis by sensor and detection by detectors on the analyticaldetector module (step 430).

In another embodiment, the flow calibration fluid is simultaneously withbody fluid sample. Analytical detector 130 can be connected tocommunication module 140 through a standardized port. When connected,communication module can provide extra mechanical and electrical powerto analytical detector 130. Once powered, analytical detector 130 canquantify the results of the chemical analysis on the assay sensor module(step 440). The results are then transferred from analytical detectormodule 130 to communication module 140 through the standard pinconnections (step 450). Communication module 140 can display the resultslocally for a user and/or transfer the results immediately or at a latertime to a central database in a remote location. The entire process,from lancing to results may take as little as a few minutes.

FIG. 5 illustrates an embodiment of the communication module within anetwork environment. An individual in a home setting 510 with portablemedical analyzer 100 can use the analyzer to sample blood. Within thedevice a series of steps are performed to gather data. Once the data isgathered, it is wirelessly transmitted 520 through a communicationnetwork 550 e.g. cellular, microwave, satellite, Internet, etc. to aremote system 570 in the hospital setting 560. The remote system caninclude computer 540 with a receiver and decoder that places the datainto a remote database 530. The computer 540 hosting the remote databasecan then process and display the information. Either a computer programor an operation at the computer terminal can send information back tothe device, such as treatment information. Alternately, the computer 540can be a network server operating communication network 550 as a WideArea Network (WAN).

FIG. 6 is a flow diagram illustrating a method 600 of operation of anembodiment of a communication module within a network environment. Inmethod 600, once the analytical detector determines medical results(step 610), one or a combination (or more) of these steps can result.The results can be displayed locally (step 620), the results can bedisplayed remotely (step 625) or the results can be stored (step 630)either locally or remotely or both. If the results are displayed, thiscan be the end of the process, or then the results can be stored. Oncethe results are stored, the computer can process the results and createresult trends (step 640). After the processing of trend results, thetrends can be displayed locally, displayed remotely, or not displayed atall. Method 600 illustrates the various methods by which the analyzercan communicate and interact with a user and a network.

Although what has been described is aimed at analysis of body fluids,this concept is easily extended. Analytical detector modules could bedeveloped to provide other diagnostic measurements such as ECG, ortemperature etc. These measurements would then take advantage of thesame communication module and communication network to transmitinformation.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

What is claimed is:
 1. A portable medical analyzer comprising: a medicalanalyzer device; an injection module positioned in the medical analyzerdevice, the injection module including a lancet, electronic drivingmechanism with an electronic brake and a sample port, wherein the sampleport delivers a medicament to a tissue site; a processor coupled to theelectronic driving mechanism; an injection module housed in the medicalanalyzer and including an interface with the port and at least onepassage way to transport the medicament to the tissue site; an injectiondetector positioned in the medial analyzer and including at least onedetector positioned to correspond to the injection module with theinjection module adapted to determine information about the injection,the injection detector configured to provide for viewing of historicalinjection data that includes patient trends, download past patientresults and show where currently injection measurements fall withinhistorical trends in non-graphic form; and a communication moduleadapted to communicate with an information system at a remote locationrelative to the sampling module, the communication module configured tocontrol local information from the injection module and at least aportion of injection information at the injection module at the remotelocation, the communication module including local storage for storinglocally collected information, with at least a portion of theinformation from the local storage being transmitted to the remotelocation to a remote location database, with at least a portion ofinformation from the remote location database being displayable.
 2. Theportable medical analyzer according to claim 1, wherein: thecommunication module includes a transmitter adapted to transferinformation to the remote location.
 3. The portable medical analyzeraccording to claim 1, wherein: the communication module includes areceiver adapted to communicate with the remote location.
 4. Theportable medical analyzer according to claim 4, wherein: the analyticaldetector module is adapted to couple via a digital media standardinterface.
 5. The portable medical analyzer according to claim 2,wherein: the transmitter is adapted to at least one interface chosenfrom radio frequency, infrared and standard ports.
 6. The portablemedical analyzer according to claim 2, wherein: the transmitter iscoupled to at least one interface chosen from radio frequency, infraredand standard ports.
 7. The portable medical analyzer according to claim2, wherein: the transmitter is adapted to communicate with the remotedatabase.
 8. The portable medical analyzer according to claim 1,wherein: the information management system includes a system for patientmanagement.
 9. The portable medical analyzer according to claim 1,wherein: the information management system includes a system foradministering the portable medical analyzer.
 10. The portable medicalanalyzer of claim 1, wherein: the information system includes anexternal database.
 11. The portable medical analyzer of claim 1,wherein: the communication module includes a receiver adapted to receiveat least one of, instructions and data from the information system, thecommunication module further including a transmitter for transmittinginformation to the information system.
 12. The portable medical analyzerof claim 1, wherein: the communication module includes a local storageunit where collected patient information can be stored.
 13. The portablemedical analyzer of claim 1, wherein: the portable medical analyzer iscoupled to a remote database.
 14. The portable medical analyzer of claim1, wherein: the remote database is hosted by a computer that processespatient information.
 15. The portable medical analyzer of claim 22,wherein: processed patient information is sent back to the patient. 16.The portable medical analyzer of claim 22, wherein: treatmentinformation is sent from the remote site to the patient.